FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Status: Recruiting
Location: See all (49) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: No
View:

• Mother has provided written informed consent to participate

• Fetal AF or SVT with or without hydrops

• Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:

• Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes or longer

• Tachycardia ≥ 170 bpm during +100% of time (≤ 30 0/7 weeks of gestation)

• Tachycardia ≥ 280 bpm (irrespective of SVA duration)

• SVT with fetal hydrops (irrespective of duration)

• Gestational age <36 0/7 weeks at time of enrollment

• Singleton Pregnancy

• Healthy mother with ± normal pre-treatment cardiovascular findings:

• ECG within normal range (sinus rhythm; QTc ≤ 0.47; PR ≤ 0.2 sec; QRS: ≤ 0.12 sec; insignificant anomalies; isolated premature beats; isolated complete right bundle

• Maternal resting heart rate ≥ 50 bpm

• Maternal systolic BP ≥ 85 mmHg

Locations
United States
Arizona
Phoenix Children's Hospital
Recruiting
Phoenix
California
University of California, San Francisco
Recruiting
San Francisco
Colorado
Children's Hospital Colorado
Recruiting
Denver
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
Florida
South Miami Hospital
Recruiting
Miami
Johns Hopkins All Children's Hospital
Recruiting
Saint Petersburg
Indiana
Deaconess Hospital
Recruiting
Evansville
Louisiana
John Ochsner Heart & Vascular Institute
Recruiting
New Orleans
John Ochsner Heart & Vascular Institute
Recruiting
New Orleans
Massachusetts
Boston Children's Hospital
Recruiting
Boston
Minnesota
Children's Health Care
Recruiting
Minnesota
Missouri
Children's Mercy Kansas City
Recruiting
Kansas City
New York
Cohen Children's Medical Centre/Northwell Health - Lake Success
Recruiting
Lake Success
Columbia University
Recruiting
New York
Ohio
Cincinnati Children's Hospital Medical Centre
Recruiting
Cincinnati
Tennessee
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Inc Pediatric Cardiology of Austin Practice
Recruiting
Austin
Texas Children's Hospital
Recruiting
Houston
Utah
University of Utah
Recruiting
Salt Lake City
Wisconsin
Children's Hospital of Wisconsin
Recruiting
Milwaukee
West Virginia
West Virginia University Research Corporation
Recruiting
Morgantown
Other Locations
Australia
The Royal Women's Hospital
Recruiting
Melbourne
Brazil
Associação Beneficente Síria - Hospital do Coração
Recruiting
São Paulo
Canada
Alberta Children's Hospital
Recruiting
Calgary
University of Alberta
Recruiting
Edmonton
London Health Sciences Centre
Recruiting
London
CHU Saine-Justine
Recruiting
Montréal
The Hospital for Sick Children
Recruiting
Toronto
The U of British Columbia
Recruiting
Vancouver
Finland
Pediatric Research Center
Recruiting
Helsinki
France
Centre Hospitalier Universitaire de Bordeaux
Recruiting
Bordeaux
Centre Hospitalier Universitaire
Recruiting
Grenoble
Hong Kong Special Administrative Region
Queen Mary Hospital
Recruiting
Hong Kong
Netherlands
Leiden University Medical Centre
Recruiting
Leiden
Russian Federation
National medical research center for obstetrics, gynecology and perinatology
Recruiting
Moscow
Spain
BCNatal - Hospital Sant Joan de Deu
Recruiting
Barcelona
Hospital Virgen de las Nieves
Recruiting
Grenada
Sweden
Queen Silvia Children's Hospital
Recruiting
Göteborg
Lund University
Recruiting
Lund
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
Recruiting
Solna
Switzerland
Inselspital Universitatsspital Bern
Recruiting
Bern
Centre Hospitalier Universitaire Vaudois
Recruiting
Lausanne
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Active, not recruiting
Birmingham
Spire Cardiff Hospital
Active, not recruiting
Cardiff
Queen Elizabeth University Hospital, Glasgow
Active, not recruiting
Glasgow
Liverpool Women's NHS Foundation Trust
Active, not recruiting
Liverpool
Chelsea and Westminster Hospital NHS Foundation Trust
Active, not recruiting
London
St George's University Hospital Foundation Trust
Active, not recruiting
London
University Hospital Southampton
Active, not recruiting
Southampton
Contact Information
Primary
Diana Balmer-Minnes, BSc, CCRP
FAST.Trial@sickkids.ca
416-813-7654
Backup
Prachi Sharma, MSc, CCRA
FAST.Trial@sickkids.ca
416-813-7654
Time Frame
Start Date: June 8, 2017
Estimated Completion Date: May 31, 2027
Participants
Target number of participants: 1000
Treatments
Prospective observational cohorts
1) Atrial flutter without fetal hydrops; 2) Atrial flutter with fetal hydrops; 3) Supraventricular tachycardia without fetal hydrops; and 4) Supraventricular tachycardia with fetal hydrops
Sponsors
Leads: The Hospital for Sick Children
Collaborators: Labatt Family Heart Centre

This content was sourced from clinicaltrials.gov

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